NA SD314.121Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982004741), received between Feb 22, 2018 and Feb 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, WHILE THE SURGEON WAS APPLYING THE 2.4 MM VARIABLE ANGLE LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE ONTO THE PATIENT, HE NOTICED THAT THE SCREWS WERE NOT ¿STAYING ON¿ THE STARDRIVE SCREWDRIVER SHAFT T8 55MM LIKE IT NORMALLY DOES. THE SURGEON AND THE SALES REP DETERMINED THAT THE STARDRIVE SCREWDRIVER SHAFT T8 55MM MUST HAVE BEEN WARPED WHICH IS WHY THE SCREWS KEPT FALLING OFF THE STARDRIVE SCREWDRIVER SHAFT T8 55MM. THE SURGEON OPTED TO PLACE THE SCREWS INTO THE PLATE BY HAND TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT, HOWEVER IT DID ADD APPROXIMATELY 5 MINUTES TO THE SURGERY. CONCOMITANT DEVICES REPORTED: 2.4 MM VARIABLE ANGLE LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE (PART # 02.111.631, LOT # UNKNOWN, QTY #1), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QTY # UNKNOWN). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289549 ↗